Label: LBEL HOMME ANTIDANDRUFF- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 19, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    ZINC PYRITHIONE 0.336 %

  • Purpose

    Antidandruff shampoo

  • Uses

    Reduces the symptoms of dandruff

  • Warnings

    For external use only

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    If condition worsens or does not improve after regular use of this product as directed, consult a doctor

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For best results use at least twice a week or as directed by a doctor.

  • Inactive ingredients

    WATER, SODIUM LAURETH SULFATE , COCAMIDE DEA, COCAMIDOPROPYL BETAINE, DIMETHICONOL, SODIUM CHLORIDE, GLYCOL DISTEARATE, FRAGRANCE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE, BUTYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE, COCO-GLUCOSIDE, TEA-DODECYLBENZENESULFONATE, HYDROLYZED SOY PROTEIN, HYDROLYZED WHEAT PROTEIN, GLYCERYL STEARATE, GLYCERYL OLEATE, MAGNESIUM NITRATE, MENTHYL PCA, ZINC CHLORIDE, GLYCERIN, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, MENTHOL, DIPROPYLENE GLYCOL, METHYLCHLOROISOTHIAZOLINONE, MAGNESIUM CHLORIDE, METHYLISOTHIAZOLINONE, APIGENIN, OLEANOLIC ACID, MORINGA PTERYGOSPERMA SEED EXTRACT, BIOTINOYL TRIPEPTIDE-1

  • SPL UNCLASSIFIED SECTION

    Puerto Rico: Distribuited by Ventura Corporation Ltd., San Juan, Puerto Rico 00924. Made in Columbia.

  • PRINCIPAL DISPLAY PANEL - 250 ml Bottle Label

    L'BEL HOMME

    Antidandruff Shampoo

    > fortified hair
    > daily use

    L'BEL
    250 ml e (8.4 fl.oz.)

    Principal Display Panel - 250 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    LBEL   HOMME ANTIDANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-426
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.00336 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    MENTHOL (UNII: L7T10EIP3A)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    APIGENIN (UNII: 7V515PI7F6)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    MORINGA OLEIFERA SEED (UNII: TIX5482832)  
    BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-426-01250 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H01/20/2012
    Labeler - Ventura Corporation Ltd (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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